FDA approves Sandoz’s two denosumab biosimilars

2024-03-06

上市批准孤儿药细胞疗法免疫疗法

FDA approves Sandoz’s two denosumab biosimilars

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来源: Pharmaceutical Technology

The FDA approval positions Wyost as a treatment to prevent skeletal-related events. Credit: BigPixel Photo / Shutterstock.com.

The US Food and Drug Administration (FDA) has approved Sandoz Sandoz’s Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz), marking the introduction of the first FDA-approved denosumab biosimilars.

These biosimilars are authorised to treat all indications of their reference medicines.

With a concentration of 120mg/1.7mL (70mg/mL), Wyost is indicated as interchangeable with its reference medicine, a human monoclonal antibody that acts on the RANKL protein, which is essential for the activation of osteoclasts.

This approval positions Wyost as a treatment to prevent skeletal-related events in patients with multiple myeloma and for those with bone metastases caused by solid tumours.

Wyost is also sanctioned for use in adults and skeletally mature adolescents with giant cell tumours in bone that are either unresectable or where surgical resection could cause significant morbidity.

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It is also approved for treating hypercalcaemia of malignancy resistant to bisphosphonate treatment.

Jubbonti is indicated to address several conditions related to bone health.

It is approved for treating high fracture risk in postmenopausal women with osteoporosis, for improving bone mass in men with osteoporosis at similar risk, and for managing glucocorticoid-induced osteoporosis in anyone with this risk.

Jubbonti is also approved to augment bone mass in men at high fracture risk due to undergoing androgen deprivation treatment for non-metastatic prostate cancer, and women receiving adjuvant aromatase inhibitor therapy for breast cancer.

Extensive clinical studies support the latest regulatory approval in the US for these biosimilars and include safety warnings within the labelling.

The approval of Jubbonti is paired with the sanctioning of Sandoz’s Jubbonti Risk Evaluation and Mitigation Strategy (REMS) programme.

The programme is tailored to educate prescribers and patients about potential severe hypocalcaemia risk, particularly in those with advanced chronic kidney disease, including those dependent on dialysis.

Sandoz North America president Keren Haruvi stated: “Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events […] disease states that can profoundly reduce the quality of life for patients.”